195P Impact of an interactive eHealth system for patient reported outcomes on safety in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated by palbociclib and endocrine therapy

Abstract

CDK 4/6 inhibitors play an important role in hormone receptor (HR)-positive, HER2-negative advanced and metastatic breast cancer. Oral medications such as palbociclib offer advantages but pose a challenge for therapy adherence. An eHealth-based platform such as CANKADO can help to support therapy management by probing the quality of life (QoL) status of the patient continuously throughout the course of treatment and, ideally, providing a basis for intensified care when indicated. PreCyle (NCT03220178) is a multicenter, randomized phase IV Intergroup trial to evaluate the impact of eHealth-based Patient-Reported Outcome (ePRO) assessment on QoL in patients with HR+ HER2-, locally advanced or metastatic breast cancer treated with palbociclib and endocrine therapy. Patients were randomized (2:1; stratified by line of treatment) to the active arm A (supported by CANKADO PRO-React) or the inform arm B (drug intake documentation only). This exploratory analysis reports the impact of CANKADO PRO-React on safety. Time to first serious adverse event (SAE) was estimated taking competing risks into account. The safety population comprised 318 patients in Arm A (23.3% SAEs) and 161 in arm B (31.1% SAEs). While distributions of adverse events (AEs) were similar by arm on the whole, patients in the CANKADO active arm had a favorable hazard ratio of 0.67 (95%-CI: 0.46-0.97; p=.04) for time to first SAE and were significantly less likely overall to suffer an SAE than patients in the inform arm. Safety analysis of the PreCycle trial demonstrates for the first time in a randomized prospective trial that interactive eHealth-based support has a substantial favorable impact on the risk of SAEs for patients with advanced and metastatic HR+/HER2- breast cancer on oral tumor therapy. While eHealth-based support may not prevent adverse events, CANKADO PRO-React could mitigate their progression to a serious adverse event, thus resulting in a substantial QoL benefit for patients.